Despite the fact that research fraud and misconduct are under scrutiny in the field of orthopaedic research, little systematic work has been done to uncover and characterise the underlying reasons for academic retractions in this field. The purpose of this study was to determine the rate of retractions and identify the reasons for retracted publications in the orthopaedic literature. Two reviewers independently searched MEDLINE, EMBASE, and the Cochrane Library (1995 to current) using MeSH keyword headings and the ‘retracted’ filter. We also searched an independent website that reports and archives retracted scientific publications (Objectives
Methods
Aims. Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. Methods. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive. Discussion. The results of this trial will provide evidence regarding clinical and cost-effectiveness between surgical and non-surgical treatment of humeral shaft fractures. Ethical approval has been obtained from East of England – Cambridge Central
Aims. Isolated fractures of the ulnar diaphysis are uncommon, occurring at a rate of 0.02 to 0.04 per 1,000 cases. Despite their infrequency, these fractures commonly give rise to complications, such as nonunion, limited forearm pronation and supination, restricted elbow range of motion, radioulnar synostosis, and prolonged pain. Treatment options for this injury remain a topic of debate, with limited research available and no consensus on the optimal approach. Therefore, this trial aims to compare clinical, radiological, and functional outcomes of two treatment methods: open reduction and internal fixation (ORIF) versus nonoperative treatment in patients with isolated ulnar diaphyseal fractures. Methods. This will be a multicentre, open-label, parallel randomized clinical trial (under National Clinical Trial number NCT01123447), accompanied by a parallel prospective cohort group for patients who meet the inclusion criteria, but decline randomization. Eligible patients will be randomized to one of the two treatment groups: 1) nonoperative treatment with closed reduction and below-elbow casting; or 2) surgical treatment with ORIF utilizing a limited contact dynamic compression plate and screw construct. The primary outcome measured will be the Disabilities of the Arm, Shoulder and Hand questionnaire score at 12 months post-injury. Additionally, functional outcomes will be assessed using the 36-Item Short Form Health Survey and pain visual analogue scale, allowing for a comparison of outcomes between groups. Secondary outcome measures will encompass clinical outcomes such as range of motion and grip strength, radiological parameters including time to union, as well as economic outcomes assessed from enrolment to 12 months post-injury. Ethics and dissemination. This trial has been approved by the lead site Conjoint Health
Introduction. Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine with unclear etiology. Due to the asymmetry of lateral curves, there are differences in the muscle activation between the convex and concave sides. This study utilized a comprehensive thoracic spine and ribcage musculoskeletal model to improve the biomechanical understanding of the development of AIS deformity and approach an explanation of the condition. Methods. In this study, we implemented a motion capture model using a generic rigid-body thoracic spine and ribcage model, which is kinematically determinate and controlled by spine posture obtained, for instance, from radiographs. This model is publicly accessible via a GitHub repository. We simulated gait and standing models of two AIS (averaging 15 years old, both with left lumbar curve and right thoracic curve averaging 25 degrees) and one control subject. The marker set included extra markers on the sternum and the thoracic and lumbar spine. The study was approved by the regional
Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health
Purpose and Background. Guidelines recommend biopsychosocial care for chronic, complex musculoskeletal conditions, including non-specific low back pain. The aims were: 1/ to assess how patients with low back pain respond to osteopathic treatment, both before and after an osteopath has completed a Biopsychosocial Pain Management (BPM) course; and 2/ to assess if it is feasible and acceptable for osteopath participants to receive weekly SCED data and use it to guide patient management. Methods and Results. A multiple baseline single case experimental design trial (. clinicaltrials.gov. , on 18/10/2021, ID number NCT05120921) with 11 UK osteopaths was conducted. Patients were randomised to early, middle or late treatment start dates. Statistical analysis assessed the change between baseline, intervention and follow-up periods. Primary outcomes were the Numeric Pain Rating (NPR) and Patient Specific Function Scales (PSFS), measured during the baseline, the 6-week intervention, and during a 12-week follow-up period. At baseline, the osteopaths reported stronger biopsychosocial attitudes to pain, compared to biomedical beliefs (PABS: 34 behavioural scale; 29 biomedical scale). Overall, patient participants showed daily increases in symptoms during the pre-treatment phase (+0.24/day, p<0.001), and daily decreases during treatment (−2.94 over the treatment phase, p<0.001), which continued post-treatment (−3.36 over 12 weeks, p=0.04). Similar improvements were observed for function. Conclusion. Osteopathic care was shown to help patients with persistent low back pain. Patient recruitment was challenging because of the randomisation. With further development, the method shows feasibility as a means of enhancing research activity among practising clinicians. Previous presentations or publications of the work. The protocol was published (. https://doi.org/10.1016/j.ijosm.2023.100660. ) and presented at SBPR in 2022. The results were presented to an osteopathic conference in October 2023. Ethics approval was received from the University College of Osteopathy
Abstract. Introduction. Skeletal muscle wasting is an important clinical issue following acute traumatic injury, and can delay recovery and cause permanent functional disability particularly in the elderly. However, the fundamental mechanisms involved in trauma-induced muscle wasting remain poorly defined and therapeutic interventions are limited. Objectives. To characterise local and systemic mediators of skeletal muscle wasting in elderly patients following acute trauma. Methods. Experiments were approved by a local NHS
The widely used Fracture Risk Assessment Tool (FRAX) estimates a 10-year probability of major osteoporotic fracture (MOF) using age, sex, body mass index, and seven clinical risk factors, including prior history of fracture. Prior fracture is a binary variable in FRAX, although it is now clear that prior fractures affect future MOF risk differently depending on their recency and site. Risk of MOF is highest in the first two years following a fracture and then progressively decreases with time – this is defined as imminent risk. Therefore, the FRAX tool may underestimate true fracture risk and result in missed opportunities for earlier osteoporosis management in individuals with recent MOF. To address this, multipliers based on age, sex, and fracture type may be applied to baseline FRAX scores for patients with recent fractures, producing a more accurate prediction of both short- and long-term fracture risk. Adjusted FRAX estimates may enable earlier pharmacologic treatment and other risk reduction strategies. This study aimed to report the effect of multipliers on conventional FRAX scores in a clinical cohort of patients with recent non-hip fragility fractures. After obtaining
Aims. Virtual fracture clinics (VFCs) are advocated by recent British Orthopaedic Association Standards for Trauma and Orthopaedics (BOASTs) to efficiently manage injuries during the COVID-19 pandemic. The primary aim of this national study is to assess the impact of these standards on patient satisfaction and clinical outcome amid the pandemic. The secondary aims are to determine the impact of the pandemic on the demographic details of injuries presenting to the VFC, and to compare outcomes and satisfaction when the BOAST guidelines were first introduced with a subsequent period when local practice would be familiar with these guidelines. Methods. This is a national cross-sectional cohort study comprising centres with VFC services across the UK. All consecutive adult patients assessed in VFC in a two-week period pre-lockdown (6 May 2019 to 19 May 2019) and in the same two-week period at the peak of the first lockdown (4 May 2020 to 17 May 2020), and a randomly selected sample during the ‘second wave’ (October 2020) will be eligible for the study. Data comprising local VFC practice, patient and injury characteristics, unplanned re-attendances, and complications will be collected by local investigators for all time periods. A telephone questionnaire will be used to determine patient satisfaction and patient-reported outcomes for patients who were discharged following VFC assessment without face-to-face consultation. Ethics and dissemination. The study results will identify changes in case-mix and numbers of patients managed through VFCs and whether this is safe and associated with patient satisfaction. These data will provide key information for future expert-led consensus on management of trauma injuries through the VFC. The protocol will be disseminated through conferences and peer-reviewed publication. This protocol has been reviewed by the South East Scotland
Aims. Surgery is often indicated in patients with metastatic bone disease (MBD) to improve pain and maximize function. Few studies are available which report on clinically meaningful outcomes such as quality of life, function, and pain relief after surgery for MBD. This is the published protocol for the Bone Metastasis Audit — Patient Reported Outcomes (BoMA-PRO) multicentre MBD study. The primary objective is to ascertain patient-reported quality of life at three to 24 months post-surgery for MBD. Methods. This will be a prospective, longitudinal study across six UK orthopaedic centres powered to identify the influence of ten patient variables on quality of life at three months after surgery for MBD. Adult patients managed for bone metastases will be screened by their treating consultant and posted out participant materials. If they opt in to participate, they will receive questionnaire packs at regular intervals from three to 24 months post-surgery and their electronic records will be screened until death or five years from recruitment. The primary outcome is quality of life as measured by the European Organisation for Research and the Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) C30 questionnaire. The protocol has been approved by the Newcastle & North Tyneside 2
Introduction and Objective. Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months. Materials and Methods. This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events. Results. The trial has been approved by The Regional Committees on Health
Background. Bone is a hierarchically structured hard tissue that consists of approximately 70 wt% low-crystallinity hydroxyapatite. Intricate tubular channels, such as Haversian canals, Volkman's canals, and canaliculi are a preserved feature of bone microstructure. These structures provide pathways for vasculature and facilitate cell-to-cell communication processes, together supporting viability of cellular components and aiding in remodeling processes. Unfortunately, many commercial bone augmentation materials consist of highly crystalline phases that are absent of the structuring present within the native tissue they are replacing. This work reports on a the development of a novel bone augmentation material that is able to generate biologically analogous tubular calcium phosphate mineral structures from hydrogel-based spheres that can be packed into defects similar to those encountered in vivo. Experimental. Calcium loaded spheres were made by adding 5 wt% agar powder to 1 M calcium nitrate solutions, before heating the mixture to 80–90 oC and feeding droplets of gel into a reservoir of liquid nitrogen. Deposition of tubular mineral was initiated by exposure to ammonium phosphate solutions at concentrations between 500 mM and 1 M, and was characterized by micro-XRF mapping, XRD and SEM techniques. For an ex vivo model, human bone tissue was collected from patients undergoing elective knee replacement surgery. The United Kingdom National
Introduction. External fixators are attached to bones with percutaneous pins and wires inserted through soft tissues and bone increasing the risk of infections. Such infections compromise patient outcomes e.g., through pin loosening or loss, failure of fixator to stabilise the fracture, additional surgery, increased pain, and delayed mobilisation. These infections also impact the healthcare system for example, increased OPD visits, hospitalisations, treatments, surgeries and costs. Nurses have a responsibility in the care and management of patients with external fixators and ultimately in the prevention of pin-site infection. Yet, evidence on best practices in the prevention of pin-site infection is limited and variation in pin-site management practices is evident. Various strategies are used for the prevention of pin-site infection including the use of different types of non-medicated and medicated wound dressings. The aim of this retrospective study was to investigate the use of dry gauze or iodine tulle dressings for the prevention of pin-site infections in patients with lower limb external fixators. Methodology. A retrospective study of patients with lower limb external fixators who attended the research site between 2015–2022. Setting & Sample: The setting was the outpatient's (OPD) orthopaedic clinic in a University Teaching Hospital in Dublin, Ireland. Eligibility Criteria:. Over the age of 16, treated with an Ilizarov, Taylor Spatial frame (TSF) or Limb Reconstruction System (LRS) external fixators on lower limbs,. Pin-sites dressed with dry gauze or iodine tulle,. Those with pre-existing infected wounds close to the pin site and/or were on long term antibiotics were excluded. Follow Up Period: From time of external fixator application to first pin-site infection or removal of external fixator. Outcome Assessment: The primary outcome was pin-site infection, secondary outcomes included but were not limited to frequency of pin-site infection according to types of bone fixation, frequency of pin/wire removal and hospitalisation due to infection. Data analysis: IBM SPSS Version 25 was used for statistical analysis. Descriptive and inferential statistics were conducted as appropriate. Categorical data were analysed by counting the frequencies (number and percentages) of participants with an event as opposed to counting the number of episodes for each event. Differences between groups were analysed using Chi-square test or Fisher's exact test, where appropriate. Continuous variables were reported using mean and standard deviations and difference analysed using a two-sample independent t-test or non-parametric test (Mann-Whitney), where appropriate. Using Kaplan-Meier, survival analysis explored time to development of infection. Ethical approval: granted by local institute
In the UK and USA in 2016 more than 263,000 primary knee replacements were performed. Around 20% of patients report chronic post-surgical pain (CPSP) at three or more months after total knee replacement (TKR). A large proportion of adults with all types of chronic musculoskeletal pain do not use services for a number of reasons, despite being in constant or daily pain. Given the high prevalence of CPSP, there is potentially a large hidden population with an unexpressed need for care, experiencing ongoing pain and disability; understanding why they do not use health services may herald further insight into why many remain dissatisfied with knee replacement surgery. The aim of this study is to understand why some people with CPSP after TKR do not access services or make little use of healthcare. We conducted face-to-face in-depth interviews with 34 patients from 2 high-volume orthopaedic hospitals in England, to investigate their experience of long-term pain after knee replacement; their knowledge and understanding of CPSP; and their decisions about consulting for CPSP. The sample size was based on achievement of saturation and participants provided written informed consent. Interviews were transcribed and analysed using an inductive thematic approach with double coding for rigor. Ethical approval for the study was granted by the West Midlands Solihull
Background. Although there are predictive equations that estimate the total fat mass obtained from multiple-site ultrasound (US) measurements, the predictive equation of total fat mass has not been investigated solely from abdominal subcutaneous fat thickness. Therefore, the aims of this study were; (1) to develop regression-based prediction equations based on abdominal subcutaneous fat thickness for predicting fat mass in young- and middle-aged adults, and (2) to investigate the validity of these equations to be developed. Methods. The study was approved by the Local
In osteoporosis treatment, current interventions, including pharmaceutical treatments and exercise protocols, suffer from challenges of guaranteed efficacy for patients and poor patient compliance. Moreover, bone loss continues to be a complicating factor for conditions such as spinal cord injury, prescribed bed-rest, and space flight. A low-cost treatment modality could improve patient compliance. Electrical stimulation has been shown to improve bone mass in animal models of disuse, but there have been no studies of the effects of electrical stimulation on bone in the context of bone loss under hormone deficiency such as in post-menopausal osteoporosis. The purpose of this study was to explore the effects of electrical stimulation on changes in bone mass in the ovariectomized rat model of post-menopausal osteoporosis. All animal protocols were approved by the institutional Animal
INTRODUCTION. The medial-stabilised (MS) knee implant, characterised by a spherical medial condyle on the femoral component and a medially congruent tibial bearing, was developed to improve knee kinematics and stability relative to performance obtained in posterior-stabilised (PS) and cruciate-retaining (CR) designs. We aimed to compare in vivo six-degree-of-freedom (6-DOF) kinematics during overground walking for these three knee designs. METHODS. Seventy-five patients (42 males, 33 females, age 68.4±6.6 years) listed for total knee arthroplasty (TKA) surgery were recruited to this study, which was approved by the relevant Human
Background. The BACK To Health programme is part of the wider North of England back pain and radicular pain pathway. The purpose of this programme is to provide a CPPP approach based on the NICE guidelines CG88 for those with back pain that has not responded to early management and simpler therapies. The purpose of this study is to present preliminary results of this programme. Method. Referral onto the programme occurred through triage and treat practitioners or consultant clinics. A total of 44 patients were referred, with 31 attending the programme. The programme was delivered as a 3 week residential programme, with patients present 9am-5pm Monday to Thursday. A MDT provided an intense programme consisting of education, physical exercise, practical coping strategies and group discussion. The work has received ethical approval from the School of Health and Social Care
Introduction. Kinematics post-TKA are complex; component alignment, component geometry and the patient specific musculoskeletal environment contribute towards the kinematic and kinetic outcomes of TKA. Tibial rotation in particular is largely uncontrolled during TKA and affects both tibiofemoral and patellofemoral kinematics. Given the complex nature of post- TKA kinematics, this study sought to characterize the contribution of tibial tray rotation to kinematic outcome variability across three separate knee geometries in a simulated framework. Method. Five 50. th. percentile knees were selected from a database of planned TKAs produced as part of a pre-operative dynamic planning system. Virtual surgery was performed using Stryker (Kalamazoo, MI) Triathlon CR and PS and MatOrtho (Leatherhead, UK) SAIPH knee medially stabilised (MS) components. All components were initially planned in mechanical alignment, with the femoral component neutral to the surgical TEA. Each knee was simulated through a deep knee bend, and the kinematics extracted. The tibial tray rotational alignment was then rotated internally and externally by 5° & 10°. The computational model simulates a patient specific deep knee bend and has been validated against a cadaveric Oxford Knee Rig. Preoperative CT imaging was obtained, landmarking to identify all patient specific axes and ligament attachment sites was performed by pairs of trained biomedical engineers. Ethics for this study is covered by Bellberry Human
Background. There is a 20% dissatisfaction rate with knee replacements. Calls for tools that can pre-operatively identify patients at risk of being dissatisfied postoperatively have been widespread. However, it is unclear what sort of information patients would want from such a tool, how it would affect their decision making process, and at what part of the pathway such a tool should be used. Methods. Using focus groups involving 12 participants and in-depth interviews with 10 participants, we examined the effect outcome prediction has by providing fictitious predictions to patients at different stages of treatment. A qualitative analysis of themes, based on a constant comparative method, is used to analyse the data. This study was approved by the Dyfed Powys